Validation & CSV Lead Engineer (15h Left)

4 days ago

Dublin, Dublin City, Ireland eir evo talent Full time
Validation & CSV Lead Engineer
Job Type: Permanent
Location: Limerick, Ireland (Fully Onsite)

The Role
The validation lead should be able to guide the team in creating the master validation plan (MVP), validation strategy, and creating the validation output document (FAT, SAT, IQ OQ PQ) aligning to business SOPs. The client is seeking to validate a new machine which will inspect the IOL. Understanding of the CSV/software in a machine will be needed. Someone who has experience with the validation of capital equipment would be ideal for this role. The resources we are seeking ideally have familiarity with customer procedures (e.g., Vision Care and or Surgical Vision).

Key Duties Include:

- Supporting validation from an automation perspective.
- Actively guiding the Añasco site in transitioning from manual to automated validation methodologies, including the development of the corresponding life cycle validation documentation and actively supporting the IQ | OQ | PQ.
- Collaborating with a CSV-specific resource (assigned). Therefore, understanding CVS is important.

Key Responsibilities:

- To have full technical oversight and lead the overall validation & qualification of the equipment and processes.
- To develop the overall validation and qualification plan strategy in compliance with onsite governing procedures and aligned with the engineering Technology department, delivering the overall project.
- Creation of quality validation process flow (e.g., V up to and including Regulatory submission).
- To promote and support an effort to have a common approach to documentation and strategies.
- To lead, support, guide, and coordinate validation activities with the team members to ensure adequate resource assignment, task prioritization, and progress monitoring according to schedule.
- Collaborate with the QA Team to ensure there is agreement to the overall strategy, resolve any issues that arise and work through the tasks to complete the overall project.
- Lead / develop the vision attribute agreement analysis test criteria (e.g., Attribute Agreement Analysis, Linearity & Bias, etc.).
- Action plan developed for each of the key deliverables.
- FAT & SAT Protocol Report and Test Plan Report completed.
- Lead the execution of IQ, OQ & PQ Testing.
- IQ | OQ | PQ Documentation Report completed.
- Validate a new machine which will inspect the IOL.
- Validation of capital equipment.

Your Profile

Key Skills/Knowledge/Experience:

- Must have: Process/Equipment Validation experience with CSV knowledge.
- Must have: A primary background in automation process validation, with an understanding (not expertise) of CSV.
- Understanding of the CSV/software in a machine will be needed.
- Validation and Compliance Knowledge:

- GxP (Good Practice) Guidelines: Familiarity with GxP guidelines such as Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP).
- FDA 21 CFR Part 11: Understanding of the regulatory requirements related to electronic records and signatures.
- ISO Standards: Familiarity with ISO 9001, ISO 13485 (for medical devices), and ISO/IEC 27001 (for information security).
- Validation Lifecycle Management: Knowledge of the entire lifecycle from planning, execution, and reporting, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).

- Computer System Validation (CSV) Expertise:

- CSV Methodologies: Strong understanding of CSV processes, including risk-based approach, qualification testing, validation protocols, and traceability matrix development.
- System Integration & Interface Testing: Skills in validating interfaces between different systems, including ensuring data integrity during integration.
- Software Testing: Experience with software test methodologies (e.g., functional, performance, stress testing).
- Documentation & Reporting: Creating and maintaining validation documentation such as protocols, reports, and deviations. Proficiency in technical writing is key.

- SCADA, SAP
- Nice to have: Work experience in the medical device industry.

Candidates should hold appropriate RTWs for Ireland i.e. Stamp1G, Stamp 4, Irish/British/EU passport.

For more information please apply here or contact Agnes Reena / agnes.reena@eirevo.ie Contact: 0858564199

eir evo talent is an equal opportunity employer who seeks to recruit and appoint the best available person for a job regardless of marital / civil partnership status, sex (including pregnancy), age, religion, belief, race, nationality and ethnic or national origin, colour, sexual orientation or disability. eir evo talent applies all relevant Data Protection laws when processing your Personal Data.

If you choose to apply to this opportunity and share your CV or other personal information with eir evo talent, these details will be held by us in accordance with our privacy policy used by our recruitment team to contact you regarding this or other relevant opportunities at eir evo talent.

Ref: EET6663

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